Sleep Initiation and Maintenance DisordersNCT02984670
Cognitive Behavior Therapy for Insomnia: Analysis of Components, Mediators and Moderators
A study testing Cognitive Therapy, Behavior Therapy and Waitlist. in people with Sleep Initiation and Maintenance Disorders, run by Stockholm University at 1 site in Sweden.
Trial summary
The overall purpose with this investigation is to further our knowledge about cognitive behavioral therapy (CBT) for insomnia by examining treatment components, mediators, and moderators. The first aim that will be addressed is to explore the efficacy of the CBT components with a dismantling-treatment strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- Cognitive Therapy, Behavior Therapy and Waitlist.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2016to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of insomnia more than three nights per week and for more than three months.
- Insomnia despite adequate opportunity to sleep.
- Insomnia severity typical for insomnia disorder, i.e. 11 points or more on the Insomnia Severity Index (ISI).
- Nighttime insomnia symptoms, i.e., two points or more on at least one of the first three ISI questions.
- Daytime insomnia symptoms, i.e. two points or more on one or both of the ISI distress and impairment items (numbers 5 and 7).
- Clinical insomnia symptoms from sleep diaries concerning three nighttime symptoms (difficulties with sleep initiation, difficulties with sleep maintenance, and early morning awakenings), i.e., thirty minutes or more on average on one or more of the symptoms.
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- No current or past CBT-I treatment within the past 5 years.
- Time and opportunity to participate in treatment for ten weeks.
- Time and opportunity to read approximately fifteen pages per week and execute homework assignments for ten weeks.
- Access to a computer, email and internet.
Who cannot join
- Severe depression, i.e., more than 30 points on MADRS-S.
- Suicidal risk, i.e., 4 points or more on item 9 on MADRS-S.
- A high intake of alcohol or caffeine,
- Insomnia due to shiftwork or other sleep-disturbing events (e.g., pregnancy, small children, or animals in the sleep environment).
- Participants with a history of psychotic or bipolar disorder.
- If a somatic condition is reported, it is required that it is relatively stable and/or that the candidate is receiving treatment for the condition.
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- When a candidate fulfills criteria for a psychiatric or somatic condition, it is required that insomnia is the disorder currently most distressing and disabling or that the insomnia remains despite treatment for the comorbid condition.
- Participants with the following primary sleep disorders will be excluded via the Duke Structured Interview for Sleep Disorders (DSISD): sleep apnea, restless legs syndrome, periodic limb movement disorder, circadian rhythm disorder, and parasomnias.
- If sleep medication is used, it is required that the use has been relatively stable during three months.
- If Selective Serotonin Reuptake Inhibitors (SSRI) use is reported, it is required that the onset of the medication was at least three months prior to the telephone interview.
- Participants who regularly consume sleep-disturbing medications.
Trial locations and contacts
1 site in 1 country.
About this study
The overall purpose with this investigation is to further our knowledge about cognitive behavioral therapy (CBT) for insomnia by examining treatment components, mediators, and moderators. The first aim that will be addressed is to explore the efficacy of the CBT components with a dismantling-treatment strategy. Two active CBT interventions, intended to define its components - cognitive therapy and behavior therapy - will be compared with one another as well as with a waitlist condition on a broad range of outcomes at five to nine assessment points depending on the measures. The design will thus enable us to examine what CBT component or components are necessary, sufficient and facilitative of therapeutic change. The second aim that will be explored is to investigate what processes occur in CBT that may contribute to treatment outcome with a treatment-mediator strategy. To examine mediators for CBT, the following mediators will be assessed; Anxiety and Preoccupation about sleep Questionnaire (APSQ), Dysfunctional Beliefs and Attitudes about Sleep (DBAS), Sleep Associated Monitoring Index (SAMI), Sleep-Related Behavior Questionnaire (SRBQ), time in bed, napping, bedtime variability, and rise time variability. The hypothesis is that cognitive processes will mediate cognitive therapy outcomes, and that behavioral factors will have a mediating role for behavior therapy improvements. The third aim that will be addressed is to examine what patient characteristics does CBT depend on to be effective with a treatment-moderator strategy. To investigate moderators for CBT, the following moderators will be assessed; age, gender, occupational status, level of education, initial insomnia severity, dysfunction, medication use, chronic pain, psychiatric co-morbidity, medical co-morbidity, behavioral and cognitive processes used as mediators will also be employed as moderators.
- Being tested
- Cognitive Therapy, Behavior Therapy, Waitlist.
- Keywords
- Cognitive therapy, Behavior therapy, Moderation, Mediation
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Negotiating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TherapyBehavioural
Cognitive Therapy involves challenging negative automatic thoughts about sleep and the use of behavioral experiments to challenge and test five cognitive processes (i.e., worry, dysfunctional thoughts, monitoring, safety behaviours, misperception) proposed to perpetuate insomnia.
Behavior TherapyBehavioural
Behavior Therapy involves the use of stimulus control and sleep restriction in order to reverse maladaptive sleep habits (time in bed, napping, bedtime variability, rise time variability) proposed to maintain insomnia. It also involves the practice of sleep hygiene principles.
Waitlist.Behavioural
The waitlist serves as a passive control which will receive the same measures administered to the cognitive and behaviour therapy groups.
| Study group | Role | What they receive |
|---|---|---|
| Behavior Therapy | Experimental | Not described Receives: Behavioral: Behavior Therapy |
| Cognitive Therapy | Experimental | Not described Receives: Behavioral: Cognitive Therapy |
| Waitlist | Other | Not described Receives: Behavioral: Waitlist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on the insomnia severity index (ISI).
Measured: Pretreatment (week 0), during treatment (i.e., at week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Secondary outcomes (10)
Changes on the Work and Social Adjustment Scale (WSAS).
Measured: Pretreatment (week 0), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Changes in sleep onset latency (SOL).
Measured: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10).
Changes in wake time after sleep onset (WASO).
Measured: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10).
Changes in early morning awakenings (EMA).
Measured: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10).
Changes in total sleep time (TST).
Measured: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10).
Changes in Hospital Anxiety and Depression Scale (HADS)
Measured: Pretreatment (week 0), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Changes in nighttime symptoms, by using item 1 - 3 from the primary outcome measure.
Measured: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Changes in impairment, by using item 5 and 6 from the primary outcome measure.
Measured: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Changes in distress, by using item 4 and 7 from the primary outcome measure.
Measured: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Changes in Brunnsviken Brief Quality of life index (BBQ)
Measured: Pretreatment (week 0), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stockholm University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markus Jansson-Fröjmark, Stockholm University
- Investigators
- Markus Jansson Fröjmark, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984670
- Sponsor's protocol ID
- CBT-I CMM
- Status last verified
- Apr 2018
- First submitted
- 21 Nov 2016
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sunnhed R, Hesser H, Andersson G, Carlbring P, Lindner P, Harvey AG, Jansson-Frojmark M. Mediators of cognitive therapy and behavior therapy for insomnia disorder: A test of the processes in the cognitive model. J Consult Clin Psychol. 2022 Sep;90(9):696-708. doi: 10.1037/ccp0000756. Epub 2022 Sep 8.
PubMed 36074617Blanken TF, Jansson-Frojmark M, Sunnhed R, Lancee J. Symptom-specific effects of cognitive therapy and behavior therapy for insomnia: A network intervention analysis. J Consult Clin Psychol. 2021 Apr;89(4):364-370. doi: 10.1037/ccp0000625. Epub 2021 Feb 25.
PubMed 33630618Sunnhed R, Hesser H, Andersson G, Carlbring P, Morin CM, Harvey AG, Jansson-Frojmark M. Comparing internet-delivered cognitive therapy and behavior therapy with telephone support for insomnia disorder: a randomized controlled trial. Sleep. 2020 Feb 13;43(2):zsz245. doi: 10.1093/sleep/zsz245.
PubMed 31608389
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavior Therapy for Insomnia: Analysis of Components, Mediators and Moderators
- ClinicalTrials.gov ID
- NCT02984670
- Acronym / sponsor ID
- CBT-I CMM
- Keywords
- Cognitive therapy, Behavior therapy, Moderation, Mediation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Stockholm UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall purpose with this investigation is to further our knowledge about cognitive behavioral therapy (CBT) for insomnia by examining treatment components, mediators, and moderators. The first aim that will be addressed is to explore the efficacy of the CBT components with a dismantling-treatment strategy. Two active CBT interventions, intended to define its components - cognitive therapy and behavior therapy - will be compared with one another as well as with a waitlist condition on a broad range of outcomes at five to nine assessment points depending on the measures. The design will thus enable us to examine what CBT component or components are necessary, sufficient and facilitative of therapeutic change. The second aim that will be explored is to investigate what processes occur in CBT that may contribute to treatment outcome with a treatment-mediator strategy. To examine mediators for CBT, the following mediators will be assessed; Anxiety and Preoccupation about sleep Questionnaire (APSQ), Dysfunctional Beliefs and Attitudes about Sleep (DBAS), Sleep Associated Monitoring Index (SAMI), Sleep-Related Behavior Questionnaire (SRBQ), time in bed, napping, bedtime variability, and rise time variability. The hypothesis is that cognitive processes will mediate cognitive therapy outcomes, and that behavioral factors will have a mediating role for behavior therapy improvements. The third aim that will be addressed is to examine what patient characteristics does CBT depend on to be effective with a treatment-moderator strategy. To investigate moderators for CBT, the following moderators will be assessed; age, gender, occupational status, level of education, initial insomnia severity, dysfunction, medication use, chronic pain, psychiatric co-morbidity, medical co-morbidity, behavioral and cognitive processes used as mediators will also be employed as moderators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Behavior Therapy | Experimental | Behavioral: Behavior Therapy |
| Cognitive Therapy | Experimental | Behavioral: Cognitive Therapy |
| Waitlist | Other | Behavioral: Waitlist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Presence of insomnia more than three nights per week and for more than three months.
- Insomnia despite adequate opportunity to sleep.
- Insomnia severity typical for insomnia disorder, i.e. 11 points or more on the Insomnia Severity Index (ISI).
- Nighttime insomnia symptoms, i.e., two points or more on at least one of the first three ISI questions.
- Daytime insomnia symptoms, i.e. two points or more on one or both of the ISI distress and impairment items (numbers 5 and 7).
Key exclusion criteria (11 listed)
- Severe depression, i.e., more than 30 points on MADRS-S.
- Suicidal risk, i.e., 4 points or more on item 9 on MADRS-S.
- A high intake of alcohol or caffeine,
- Insomnia due to shiftwork or other sleep-disturbing events (e.g., pregnancy, small children, or animals in the sleep environment).
- Participants with a history of psychotic or bipolar disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive TherapyCognitive Therapy involves challenging negative automatic thoughts about sleep and the use of behavioral experiments to challenge and test five cognitive processes (i.e., worry, dysfunctional thoughts, monitoring, safety behaviours, misperception) proposed to perpetuate insomnia. | Behavioural | Cognitive Therapy |
| Behavior TherapyBehavior Therapy involves the use of stimulus control and sleep restriction in order to reverse maladaptive sleep habits (time in bed, napping, bedtime variability, rise time variability) proposed to maintain insomnia. It also involves the practice of sleep hygiene principles. | Behavioural | Behavior Therapy |
| Waitlist.The waitlist serves as a passive control which will receive the same measures administered to the cognitive and behaviour therapy groups. | Behavioural | Waitlist |
Primary outcome
Changes on the insomnia severity index (ISI).
Time frame: Pretreatment (week 0), during treatment (i.e., at week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
10 secondary outcomes
Changes on the Work and Social Adjustment Scale (WSAS).
Time frame: Pretreatment (week 0), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Changes in sleep onset latency (SOL).
Time frame: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10).
Changes in wake time after sleep onset (WASO).
Time frame: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10).
Changes in early morning awakenings (EMA).
Time frame: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10).
Changes in total sleep time (TST).
Time frame: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8) and post-treatment (week 10).
Changes in Hospital Anxiety and Depression Scale (HADS)
Time frame: Pretreatment (week 0), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Changes in nighttime symptoms, by using item 1 - 3 from the primary outcome measure.
Time frame: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Changes in impairment, by using item 5 and 6 from the primary outcome measure.
Time frame: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Changes in distress, by using item 4 and 7 from the primary outcome measure.
Time frame: Pretreatment (week 0), during treatment (week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Changes in Brunnsviken Brief Quality of life index (BBQ)
Time frame: Pretreatment (week 0), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Derived from this study: PubMed 36074617Sunnhed R, Hesser H, Andersson G, Carlbring P, Lindner P, Harvey AG, Jansson-Frojmark M. Mediators of cognitive therapy and behavior therapy for insomnia disorder: A test of the processes in the cognitive model. J Consult Clin Psychol. 2022 Sep;90(9):696-708. doi: 10.1037/ccp0000756. Epub 2022 Sep 8.
- Derived from this study: PubMed 33630618Blanken TF, Jansson-Frojmark M, Sunnhed R, Lancee J. Symptom-specific effects of cognitive therapy and behavior therapy for insomnia: A network intervention analysis. J Consult Clin Psychol. 2021 Apr;89(4):364-370. doi: 10.1037/ccp0000625. Epub 2021 Feb 25.
- Derived from this study: PubMed 31608389Sunnhed R, Hesser H, Andersson G, Carlbring P, Morin CM, Harvey AG, Jansson-Frojmark M. Comparing internet-delivered cognitive therapy and behavior therapy with telephone support for insomnia disorder: a randomized controlled trial. Sleep. 2020 Feb 13;43(2):zsz245. doi: 10.1093/sleep/zsz245.
- Comparative Efficacy of Behavior Therapy, Cognitive Therapy, and Cognitive Behavior Therapy for Chronic Insomnia: A Randomized Controlled TrialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Jansson Fröjmark, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Therapy, Behavior Therapy and Waitlist. in people with Sleep Initiation and Maintenance Disorders, run by Stockholm University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes on the insomnia severity index (ISI). (time frame: Pretreatment (week 0), during treatment (i.e., at week: 2, 4, 6, 8), post-treatment (week 10) and follow-up at 6, 12, and 18 month after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02984670, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.